Principal Design Assurance Engineer

Healthcare Professionals Group; Sydney; Sur place; AUD 180 000 - 240 000; Plein temps

Résumé du poste

Healthcare Professionals Group in Sydney is seeking a Principal Design Assurance Engineer to lead technical challenges across high-risk medical device programs. This role blends hands-on engineering with strategic influence, overseeing design controls, risk management and V&V across design, systems and quality domains.

You’ll mentor engineers, collaborate with Product Development, and play a key role when regulators come asking questions, ensuring robust technical decisions and evidence.

Qualifications

• Experience developing regulated medical devices.
• Expertise across design controls and risk management.
• Ability to respond to regulator queries.

Responsabilités

• Act as a senior technical voice across complex medical device development programs.
• Guide engineering on critical design and product decisions.
• Apply design controls and ISO14971 risk management throughout development.
• Review requirements, architecture, risk controls and V&V evidence.
• Contribute to complex technical investigations with Product Development.
• Respond to regulator questions and support regulatory submissions.
• Mentor engineers and strengthen Design Assurance capability.

Connaissances

Design Assurance

Systems Engineering

V&V

Regulatory Judgement

Mentoring

Risk Management

Regulatory Submissions

Medical Devices

Outils

ISO13485

ISO14971

21 CFR 820

Regulatory Submissions

Description du poste

Principal Design Assurance Engineer | Technical Lead | Medical Devices

Benefits

• Operate at Principal level, solving complex technical and design challenges
• Influence critical decisions across high-risk, implantable medical device development
• Stay hands-on technically while gaining greater strategic influence and autonomy
• Across design, systems, risk and V&V – not just Quality
• Become a technical mentor and help shape Design Assurance capability

About the Company

Join an innovative Sydney-based medical device organisation developing sophisticated implantable technology for patients globally.

You’ll join in a multidisciplinary environment alongside experienced Engineering, Systems, Quality, and Regulatory professionals, contributing to technically complex products where strong engineering judgement is critical.

About the Opportunity

This isn’t a traditional Quality role.

It’s a Principal level technical position within Design Assurance for an experienced engineer who enjoys getting into the difficult problems: challenging designs, interrogating technical evidence and helping teams find the right path when the answer isn’t obvious.

You’ll collaborate with Product Development to ensure design decisions, risk controls and V&V strategies are technically robust, and you’ll play a key role when regulators come asking questions.

Your influence will come from technical credibility, sound judgement and the ability to guide others through complex problems.

What You’ll Be Doing

• Acting as a senior technical voice across complex medical device development programs
• Challenging and guiding Engineering on critical design and product decisions
• Applying design controls and ISO14971 risk management throughout development
• Reviewing requirements, architecture, risk controls and V&V evidence
• Contributing substantially to complex technical investigations alongside Product Development
• Responding to regulator questions and supporting regulatory submissions
• Mentoring engineers and strengthening Design Assurance capability across the team

Why It’s Worth It

• Take the step from Senior Engineer to genuine Principal level influence
• Tackle challenging technical problems rather than simply reviewing documentation
• Build your career on technical depth without needing to pursue people management
• Work on sophisticated technology where risk, reliability and patient safety matter

What You’ll Bring

• Significant experience developing regulated medical devices
• Deep technical capability across Design Assurance, Systems Engineering, V&V, Design Quality or Product Development
• Strong understanding of design controls, ISO13485, ISO14971 and 21 CFR 820
• Experience supporting regulatory submissions and responding to regulator queries
• Strong regulatory judgement: you know not only whether something works technically, but whether the rationale and evidence will withstand scrutiny
• Confidence challenging experienced engineers and recommending alternative approaches
• Experience mentoring and developing technical capability in others
• Experience with Class II/III, implantable, connected or software-driven devices is highly regarded

Culture

You’ll join a technically driven, collaborative environment where Quality and Engineering work closely together.

This role suits someone who asks “why?”, challenges assumptions and enjoys working through difficult problems with experienced engineers. You’ll be trusted to contribute your expertise, recommend solutions and help others develop stronger technical judgement.

If you’re an experienced Principal Engineer, Design Assurance Engineer, Systems Engineer, V&V Engineer or Design Quality Engineer looking for greater technical ownership and influence, we’d like to hear from you.